Label: FOLLICLE FOLLIXIL 5% MINOXIDIL HAIR REGROWTH-LOTION liquid

  • NDC Code(s): 84148-005-01
  • Packager: Guangzhou Ariel Biotech Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 17, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Minoxidil 5%

  • Purpose

    Hair regrowth treatment for men.

  • Use

    to regrow hair on the top of the scalp (vertex only, see pictures on side of carton.

  • Warnings

    For external use only. For use by men only.

    Flammable: Keep away from fire or flame

  • Do not use

    ●You are a woman.
    ●Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the
    scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
    ●You have no family history of hair loss.
    ●Your hair loss is sudden and/or patchy.
    ●You do not know the reason for your hair loss.
    ●You are under 18 years of age. Do not use on babies and children.
    ●Your scalp is red, inflamed, infected, iritated or painful.
    ●You use other medicines on the scalp.

  • WHEN USING

    ●Do not apply on other parts of the body.
    ●Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
    ●Some people have experienced changes in hair color and/or texture.
    ●It takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to
    use this product for at least 4 months before you see results.
    ●The amount of hair regrowth is different for each person. This product will not work for all men.

  • STOP USE

    ●Chest pain, rapid heartbeat, faintness or dizziness occurs.
    ●Sudden, unexplained weight gain occurs.
    ●Your hands or feet swell.
    ●Scalp iritation or redness occurs.
    ●Unwanted facial hair growth occurs.
    ●You do not see hair regrowth in 4 months.

  • KEEP OUT OF REACH OF CHILDREN

    May be harmful if used when pregnant or breast-feeding. Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    ●Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.
    ●Using more or more often will not improve results.
    ●Continuous use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

  • Other information

    1.See hair loss pictures on side of this carton.
    2.Before use, read all information on carton and enclosed leaflet.
    3.Keep the carton. It contains important information.
    4.Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil
    topical solution 5% for men.
    5.In clinical studies with mostly white men aged between 18-49 years with moderate degrees of hair loss, monoxidil topical
    solution 5% for men provided more hair regrowth than minoxidil topical solution 2%,
    6.Store at 20° to 259C (68° to 77°F). Keep tightly closed.

  • Inactive ingredients

    Water, Alcohol, Propylene Glycol, Glycerol, Biotin, Caffeine, Niacinamide

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    FOLLICLE FOLLIXIL 5% MINOXIDIL HAIR REGROWTH-LOTION 
    follicle follixil 5% minoxidil hair regrowth-lotion liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84148-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BIOTIN (UNII: 6SO6U10H04)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CAFFEINE (UNII: 3G6A5W338E)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84148-005-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/17/2024
    Labeler - Guangzhou Ariel Biotech Co., Ltd. (402818771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Ariel Biotech Co., Ltd.402818771manufacture(84148-005)